FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3405499
·
Received October 11, 2013
Report
- Report Number
- 6000034-2013-01790
- Event Type
- Injury
- Date Received
- October 11, 2013
- Date of Event
- September 19, 2013
- Report Date
- October 24, 2013
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED OCTOBER 25, 2013.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT, PAIN AROUND THE IMPLANT SIDE AND HEADACHES WITH DEVICE USE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED (B)(6) 2013, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522676 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD | CI24M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Required Intervention |